May 2005

The purpose of this letter is to alert you to changes in the labeling of Fleet Phospho-soda Oral Saline Laxative. As you may know, Fleet Phospho-soda Oral Saline Laxative: -  is frequently prescribed by physicians for use as a bowel cleanser prior to colonoscopy, other endoscopic and radiologic examinations and surgery; -  Has been extensively studied using two 45 mL doses, administered 10-12 hours apart, confirming the product's safety and efficacy profile; -  has become the leading (in terms of units) bowel purgative; and-  is widely accepted for use as a bowel cleanser by physicians. C.B. Fleet Company has recently made changes in the labeling on the retail packaging of Fleet Phospho-soda to improve patient compliance. These changes include: -  separate dosing for laxative use and for use prior to medical procedures -  dosing in tablespoons rather than teaspoons -  identification of the number of tablespoons in each bottle -  more detail on amount of clear liquid to be taken with the product -  addition of a statement to the flap that 'Overdoses Can Be Harmful" -  additional statements that the 90 mL product is a Multidose             Container" -  addition of toll free number (1-888-999-9711) for consumers to call with questions. See new label on the reverse side of this alert. We encourage you to become familiar with the changes so you can advise your patients on the proper use of the product. We also strongly urge you to encourage patients whoa re prescribed the product to drink large amounts of clear liquids. Doing so helps ensure a clean bowel and helps prevent dehydration and the serious side effects that can occur from dehydration when taking a saline laxative such as Fleet Phospho-soda. Last, the professional labeling for the product, as provided in the PDR, and made available to physicians, has been amended to add additional warning information. Thank you for your attention to this important matter. We believe the changes will assist pharmacists, as well as physicians, and most importantly, patients in assuring proper use of Fleet Phospho-soda. For further information about use of Fleet Phospho-soda, please visit http://www.phosphosoda.com or call 1-888-999-9711, ext 8486.

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